As diabetes soars, so do research and treatment options

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Last week, the British Medical Journal reported that 35% of adults in the UK have “pre-diabetes,” a condition that increases their risk of developing diabetes up to 10 times. That’s a significant leap from 2003, when only 11.6% of the population was prediabetic, and it echoes findings elsewhere.

According to the American Association of Clinical Endocrinologists, 35% of the U.S. population has pre-diabetes (approximately 79 million people) and 10% of the healthcare budget is spent on diabetes-related conditions.

The rapid increase of diabetes and related conditions in the two nations -- and elsewhere -- is alarming to public health experts, who have predicted that the cost of treating people long term can bankrupt entire health care systems.

India, in particular, has seen a precipitous increase in the number of people with pre-diabetes and diabetes. According to data from the Council of Medical Research India Diabetes Study, 11% of adults in India have pre-diabetes. The number of people with diabetes in India increased from 50.8 million in 2011 to 62.4 million in 2013, and experts predict that by 2030, 101 million people in India will have diabetes.

But as these numbers have soared, dozens of new treatments are being developed. The question is: Will they help -- and are so many options needed?

.Increasing prevalence, decreasing death rate

According to a report published by the Pharmaceutical Researchers and Manufacturers of America (PhRMA) this year, there are 180 medicines in development to treat diabetes, pre-diabetes and diabetes-related diseases, which may lead some to ponder why so much drug development is needed when so many treatments already exist. Though nutritional and lifestyle changes can improve metabolic health significantly, ultimately medication plays a significant role in treating diabetes, with the goal of tightly controlling blood sugar and therefore averting expensive, life-limiting complications.

“We know that achieving weight, food intake and exercise goals in our patients is very difficult and because of this reality, medications are needed in the therapeutic algorithm,” said Dr. Barry Mennen, a Washington-based physician who helps diabetic, nondiabetic and prediabetic patients achieve better blood sugar and weight control.

There are currently 60 active diabetes-related clinical trials and another 140 that are recruiting subjects. Diabetes is one area in which innovation has played a role in improving outcomes. Between 1997 and 2006, the death rate from diabetes fell by 40% -- in large part because of the effectiveness of medical management.

Mennen, who spent 30 years as a full-time pharmaceutical industry strategist and still consults, notes that the largest breakthroughs since the mid-1950s have occurred in the last 10 years.

He explains, “Three new classes of medications have been game-changers for patients, including the GLP analogues, such and Byetta and Victoza; the dipeptidyl peptidase 4 (DPP-4 inhibitors), also known as gliptins, such as Januvia and Onglyza and the SGLT-2 inhibitors, such as Invokana and Farxiga.

"However, two basic targets still remain: decreasing insulin resistance in the major target tissues of the liver and skeletal muscles and enhancing beta cell secretion of insulin,” he said.

A promising pipeline

The pipeline is full of potentially promising drugs for diabetes and diabetes-related conditions. Some examples include a drug that improves glucose-dependent insulin resistance; another that inhibits the enzyme linked to diabetic neuropathy and one designed to kick-start the regeneration of insulin-producing cells.

Although many of the drugs in development have similar mechanisms of action to currently approved drugs, there are still many ways to improve them, for example by improving side-effect profile and dosing frequency.

“Developing effective drugs that offer treatments for the microvascular complications of retinopathy, nephropathy and neuropathy would be a significant advance for those patients with advanced disease,” Mennen said.

The cost-benefit analysis of using medication to address diabetes is very clear. According to information from PhRMA, on average, a year of medication and supplies costs $4,110. However, a year of hemodialysis costs $8,700; amputation costs $40,000 and an average hospital stay costs $10,000.

Thus, the goal of the researchers currently working in diabetes drug development is clear: Improve outcomes so fewer patients end up with the most severe, disabling and expensive outcomes.